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510(k) K242861

TrueLok Elevate by Orthofix Srl — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2024
Date Received
September 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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